Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64945–64968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2005
IMPLANT HANDPIECES
K051661 · EKX
Sirona Dental Systems GmbH
Dental · 76d
Cleared Sep 06, 2005
TAPERED COMPRESSION PIN
K051740 · JDW
Nexa Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 06, 2005
SBI WRISTFIT
K051747 · HRS
Small Bone Innovations, LLC
Orthopedic · 69d
Cleared Sep 06, 2005
OSTEOMIMETIC SYNTHETIC BONE MATRIX
K051775 · MQV
Biomimetic Pharmaceuticals, Inc.
Orthopedic · 67d
Cleared Sep 06, 2005
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
K051820 · OAR
Arthrocare Corp.
Orthopedic · 63d
Cleared Sep 06, 2005
PREMIER TEMPORARY CEMENT
K051866 · EMA
Premier Dental Products Co.
Dental · 57d
Cleared Sep 06, 2005
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650...
K051915 · DFH
The Binding Site, Ltd.
Immunology · 53d
Cleared Sep 06, 2005
MIOT PLATING SYSTEM
K051945 · HRS
Orthofix Srl
Orthopedic · 50d
Cleared Sep 06, 2005
POROUS COATED DISCOVERY ELBOW
K051975 · JDC
Biomet, Inc.
Orthopedic · 47d
Cleared Sep 06, 2005
R&R EXTERNAL FIXATION SYSTEM
K052005 · KTT
R&R Medical, Inc.
Orthopedic · 43d
Cleared Sep 06, 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · DYB
Terumo Medical Corp.
Cardiovascular · 26d
Cleared Sep 06, 2005
VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
K052209 · DPW
Vascular Control Systems, Inc.
Cardiovascular · 22d
Cleared Sep 06, 2005
SC CERAMIC BALL HEADS
K052237 · LZO
Orthopedic Alliance, LLC
Orthopedic · 20d
Cleared Sep 02, 2005
SEER MC
K042782 · MLO
Ge Medical Systems Information...
Cardiovascular · 331d
Cleared Sep 02, 2005
DOLOTENS DENTAL TM 1
K043373 · KZM
Neuromuscular Technologies, Inc.
Dental · 268d
Cleared Sep 02, 2005
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · KCY
Zimmer, Inc.
General & Plastic Surgery · 197d
Cleared Sep 02, 2005
ACCU-LEAD
K050443 · DRX
Kentec Medical, Inc.
Cardiovascular · 192d
Cleared Sep 02, 2005
ANGIOSCULPT SCORING BALLOON CATHETER
K050629 · PNO
Angioscore, Inc.
Cardiovascular · 175d
Cleared Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
K050863 · DQO
Boston Scientific Corp
Cardiovascular · 150d
Cleared Sep 02, 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999 · FMF
Jiangxi Sanxin (Eversincere) Medical...
General Hospital · 135d
Cleared Sep 02, 2005
INTERMEZZO IMPLANT SYSTEMS
K051018 · DZE
Megagen Co., Ltd.
Dental · 134d
Cleared Sep 02, 2005
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
K051035 · HQD
Synergeyes
Ophthalmic · 133d
Cleared Sep 02, 2005
MANIPUSEAL
K051160 · HEW
Insitu Systems
Obstetrics & Gynecology · 120d
Cleared Sep 02, 2005
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K051507 · DZE
Blue Sky Bio, LLC
Dental · 87d